UPDATES FOR HEALTH PROFESSIONALS

Office of Health and Constituent Affairs

ANNOUNCEMENTS

FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine

One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies. Recent advances in our basic knowledge of the pathways involved in tissue damage and regeneration have combined with remarkable progress in adult stem cell biology to put us at a genuine inflection point in the history of medicine. The prospect of clinical tissue repair strategies is a tangible reality. This promise is reinforced by the strong commitment of the investment and scientific communities in exploring the potential applications across a wide range of vexing diseases and conditions, such as cancer, Parkinson’s disease, and diabetes, among many others. More information

FDA’s role in ensuring Americans have access to clear and consistent calorie and nutrition information; forthcoming guidance will provide greater clarity and certainty

As a doctor, father and the head of the U.S. Food & Drug Administration, I believe that everyone is entitled to the information they need to make informed decisions about the food they eat. We serve as the nation’s expert on food labeling, which is why Congress entrusted us with the responsibility of crafting predictable, uniform federal standards that will benefit the health of families across America by ensuring access to essential calorie and nutrition information on food and menu labels. Americans should not have to navigate variable information about the foods they eat when traveling from state to state—or city to city. Inconsistent state and local requirements may also drive up the cost of food, and sow confusion, by requiring restaurants and other covered establishments to post different information based on location. More information

Interoperability: FDA’s Final Guidance on Smart, Safe, Medical Device Interactions

Imagine an intensive care unit for newborns. An interface on a device called a pulse oximeter is sending data on changes in the newborns’ blood oxygen level to a hospital computer system that simultaneously gathers data from EKGs that are monitoring the electrical activity of their hearts. By synchronizing time and information with the pulse oximeter, an EKG is able to identify important signals from the oximeter, information that will ultimately lead to smarter care. “Interoperability” is when devices talk to each other in a safe and effective way enabling smarter care. Today’s health care providers and their patients are relying more than ever on rapid, secure interactions among different medical devices. More information

Safety concerns related to investigational use of Keytruda in multiple myeloma

Clinical trials play a critically important role in bringing to market innovative new therapies for patients facing life-threatening disease. It is an exciting time for medical innovation. Already, clinical trials have helped realize exciting and meaningful advancements for patients with critical diseases, like cancer, and thousands of clinical trials are currently underway looking at experimental therapies, combinations of therapies and new uses for existing therapies. But with this hope comes the understanding that there are inherent risks for patients who are willing to participate in this type of research. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Use of Real World Evidence to Support Regulatory Decision-Making for Medical Devices

The FDA is announcing the availability of the guidance entitled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” FDA is issuing this guidance to clarify how we evaluate real-world data to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in FDA Start Printed Page 41419regulatory decision-making for medical devices. The guidance describes the circumstances when real-world evidence can be used, and the scientific criteria that must be fulfilled in order to have confidence in the data. Finally, the guidance describes some examples of actual uses of real-world evidence that have already led to FDA decisions.The announcement of the guidance is published in the Federal Register on August 31, 2017. More information

Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff

The FDA is announcing the availability of the draft guidance entitled “Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices—Draft Guidance for Industry and Food and Drug Administration Staff.” When final, this draft guidance will clarify FDA's policy related to compliance with applicable performance standards and conformance to International Electrotechnical Commission (IEC) consensus standards for ultrasonic diathermy devices. This draft guidance will also provide recommendations for information to provide in 510(k) submissions for ultrasonic diathermy devices. This draft guidance is not final nor is it in effect at this time. More information

PRODUCT APPROVALS & CLEARANCES

FDA clears mammography device with option for patient-assisted compression

The FDA cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken. "Regular mammograms are an important tool in detecting breast cancer," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. "However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram. This device allows patients some control over the amount of compression for their exam." More information

FDA approves Mylotarg for treatment of acute myeloid leukemia

The FDA approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory). More information

FDA approval brings first gene therapy to the United States

The FDA issued a historic action making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). “We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Scott Gottlieb, M.D. “New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses. At the FDA, we’re committed to helping expedite the development and review of groundbreaking treatments that have the potential to be life-saving.” More information

FDA approves new antibacterial drug

The FDA approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria. “The FDA is committed to making new safe and effective antibacterial drugs available,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. More information

FDA approves first U.S. treatment for Chagas disease

The FDA granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease. Chagas disease, or American trypanosomiasis, is a parasitic infection caused by Trypanosoma cruzi and can be transmitted through different routes, including contact with the feces of a certain insect, blood transfusions, or from a mother to her child during pregnancy. After years of infection, the disease can cause serious heart illness, and it also can affect swallowing and digestion. More information

For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed

PRODUCT SAFETY

MedWatch, The FDA Safety Information and Adverse Event Reporting Program

For important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch. To receive MedWatch Safety Alerts by email subscribe here.

FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients

The FDA took decisive action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego, California, and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California. On behalf of the FDA, the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live) – a vaccine that is reserved only for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine, and although one vial was partially used, four of the vials were intact. More information

Hydromorphone HCl Injection, USP 2 mg/mL, and Levophed (Norepinephrine Bitartrate Injection, USP) 4 mg/4 mL (1 mg/mL) Vial by Hospira: Recall - Lack of Sterility Assurance

Hospira is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII 2 mg/mL and four lots of Levophed (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. The possibility of a breach in sterility assurance in distributed product, while not confirmed, cannot be eliminated. No batches of product have been identified as containing microorganisms. To date, Hospira has not received reports of any adverse events associated with this issue for these lots. See the press release for lot numbers recalled. In the event that impacted product is administered to a patient, adverse events ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection could occur. More information

Unexpired Lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose by PharMEDium - Recall - Sub-Potency

PharMEDium Services, LLC (PharMEDium) is voluntarily recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose products that were produced between July 6, 2017 and August 29, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of Oxytocin compounded with Lactated Ringers and Oxytocin Compounded with Lactated Ringers and Dextrose which would lead to a lower dose being administered. Although oxytocin is titrated based on clinical response, an extreme and unexpected reduction in dose than expected could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of patient's conditions. More information

Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products: FDA Alert - Lack of Sterility Assurance and Other Quality Issues

The FDA is alerting health care professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. These products are distributed by Total Resources International, Walnut, California, and Simple Diagnostics Inc., Williston Park, New York. The use of these alcohol pads and antiseptic towelettes could cause infections. FDA initially contacted Foshan on May 25, 2017, regarding a recall, and had several follow-up meetings with the company. However, Foshan has not taken action to remove its alcohol pads or antiseptic towelettes from the market. More information

Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold

Based on data from two recently halted clinical trials, the U.S. Food and Drug Administration today is issuing this statement to inform the public, health care professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma. The FDA statement is based on review of data from two clinical trials (KEYNOTE-183 and KEYNOTE-185) evaluating the use of Keytruda (pembrolizumab) combined with other treatments in patients with multiple myeloma. More information

Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira: Recall - Presence of Particulate Matter

Hospira is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions. In the event the particulate is administered to a patient, it may result in phlebitis, end-organ granuloma or micro-embolic effects, or gastrointestinal trauma. The risk is reduced by the possibility of detection. The label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration. More information

Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup: Recall - Potential Contamination with Burkholderia cepacia

Mid Valley Pharmaceutical is recalling lot# 23221701 of Doctor Manzanilla Cough & Cold and lot# 23221701 of Doctor Manzanilla Allergy & Decongestant Relief syrup to the consumer level. The products may potentially be contaminated with the bacteria Burkholderia cepacia. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems. To date, Mid Valley Pharmaceutical, LLC has not received any reports of adverse events related to this recall. BACKGROUND: Doctor Manzanilla Cough & Cold is sold over the counter for relief of cough, nasal decongestion, throat irritation, sneezing, itching watery eyes, and bronchial irritation. Doctor Manzanilla Allergy & Decongestant Relief is sold over the counter for relief of allergy, nasal decongestion, itchy throat, sneezing, itchy watery eyes, and as an antihistamine. More information

Piyanping Anti-Itch Lotion: Recall - Incorrect Active Ingredient

Lucky Mart Inc. is voluntarily recalling lots C14005, C16001 and C16002 of Piyanping Anti-Itch Lotion to the consumer level. The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Dexamethasone is not listed as an ingredient in the labeling. Dexamethasone is a higher potency steroid than hydrocortisone and may have a longer half-life; it could potentially cause serious side effects in patients applying the cream multiple times daily. There is a reasonable probability of any or all of the following side effects of topical steroids which include but are not limited to skin changes (whitening, thinning), adrenal suppression (high blood sugar, weakened immunity, electrolyte imbalances, emotional lability, slowing of growth in children), glaucoma, and cataracts. To date Lucky Mart Inc. has not received any reports of adverse events related to this recall. More information

Forced Air Thermal Regulating Systems: Healthcare Provider Letter - Information About Use

The FDA is reminding health care providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients. The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery). After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection. Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. More information

Implantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication - Firmware Update to Address Cybersecurity Vulnerabilities

The FDA approved a firmware update that is now available and is intended as a recall, specifically a corrective action, to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities for certain Abbott (formerly St. Jude Medical) pacemakers. The firmware update will be available beginning August 29, 2017. Pacemakers manufactured beginning August 28, 2017 will have this update pre-loaded in the device and will not need the update. The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical's RF-enabled implantable cardiac pacemakers and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user (i.e. someone other than the patient's physician) to access a patient's device using commercially available equipment. More information

Ninjacof and Ninjacof A: Recall - Potential Burkholderia Cepacia Contamination

Centurion Labs is voluntarily recalling 1 lot of Ninjacof (Lot# 200N1601) and 1 lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet and distributed by Centurion Labs to the retail level due to potential contamination with Burkholderia cepacia. Centurion was notified by the FDA regarding the potential contamination as they discovered this product may have been manufactured in a Pharmatech, FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia. Products are sold in 473 mL bottles with the expiration date of 11/2018. The affected products are Ninjacof with Lot# 200N1601 (NDC 23359-032-16) and Ninjacof A with Lot# 201NA1601 (NDC 23359-033-16) and both were distributed within the following states: Alabama, Arkansas, Florida, Georgia, Louisiana, Missouri, Mississippi, New Jersey, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee, and Texas. See press release for product photos. More information

UPCOMING MEETINGS

FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee.

Other types of meetings listed may require prior registration and fees. Click on "more information" for details about each meeting.

Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings.

Pediatric Trial Design and Modeling: Moving into the Next Decade (Sep 8)

The Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration is announcing a public workshop entitled “Pediatric Trial design and Modeling: Moving into the next decade” More information

Pediatric Advisory Committee Meeting Announcement (Sep 11)

The Pediatric Advisory Committee will meet to discuss the use of prescription opioid products containing hydrocodone or codeine for the treatment of cough in pediatric patients. The discussion will include current practice for the treatment of cough in children and benefit-risk considerations regarding the use of prescription opioid products in pediatric patients. More information

Pediatric Advisory Committee Meeting Announcement (Sep 12)

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for Abilify (aripiprazole), Keppra and Keppra XR (levetiracetam), CONTEGRA Pulmonary Valved Conduit (humanitarian device exemption (HDE), ENTERRA Therapy System (HDE), PLEXIMMUNE (HDE), and ELANA Surgical Kit (HDE). More information

Reducing the Risk of Preventable Adverse Drug Events associated with Hypoglycemia in the Older Population (Sep 12)

FDA's Center for Drug Evaluation and Research, Professional Affairs and Stakeholder Engagement Staff (PASES), is hosting a one day public workshop entitled “Reducing the Risk of Preventable Adverse Drug Events associated with Hypoglycemia in the Older Population.” The purpose of this workshop is to discuss the importance of individualized glycemic control targets for older patients with diabetes, in order to reduce the risk of serious hypoglycemia, identify and discuss medication safety efforts, both those that are part of the Safe Use Initiative and those external to FDA, that are of direct relevance and importance to older patients living with the disease, discuss future areas of research which could be explored to reduce the risk of serious hypoglycemia in older diabetic patients, and disseminate the results of this discussion to inform patients, patient advocates, and healthcare practitioners. More information

Vaccines and Related Biological Products Advisory Committee Meeting Announcement (Sep 13)

On September 13, 2017, the Vaccines and Related Biological Products Committee (VRBPAC) will meet in an open session to discuss and make recommendations on the safety and effectiveness of Zoster Vaccine Recombinant (Adjuvanted) [Shingrix], manufactured by GlaxoSmithKline Biologicals. More information

UPDATED PUBLIC PARTICIPATION INFORMATION: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement (Sep 14)

The public participation information has been changed for the September 14, 2017, joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The deadline for making formal oral presentation requests has been changed from Tuesday, August 22, 2017 to Monday, August 28, 2017 and the contact person will now notify interested persons regarding their request to speak by Tuesday, August 29, 2017. All other information remains the same. More information

Public Workshop- Advancing the Development of Pediatric Therapeutics (ADEPT): Application of "Big Data" to Pediatric Safety Studies (Sep 18-19)

The Office of Pediatric Therapeutics, Food and Drug Administration (FDA) is announcing a public workshop entitled “Advancing the Development of Pediatric Therapeutics (ADEPT): Application of “Big Data” to Pediatric Safety Studies”. The purpose of this two day workshop is to understand: 1. how to access and analyze “Big Data” associated with safety information in the healthcare setting. 2. the utility and challenges associated with the use of “Big Data” to study the safety of therapeutics in children.More information

Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement (Sep 19)

The committee will discuss supplemental new drug application (sNDA) 021938/033 SUTENT (sunitinib malate) oral capsules, submitted by C.P. Pharmaceuticals International C.V., represented by Pfizer, Inc. (authorized U.S. agent). The proposed indication (use) for this product is for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy. More information

Peripheral and Central Nervous System Drugs Advisory Committee (Sep 28)

The committee will discuss new drug application (NDA) 200896, ataluren for oral suspension, sponsored by PTC Therapeutics, Inc., for the treatment of patients with dystrophinopathy due to a nonsense mutation in the dystrophin gene. More information

Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review; Public Workshop (Oct 2 - 3)

The FDA is announcing a public workshop entitled “Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review.” The workshop is intended to (1) engage stakeholders in a discussion of current and emerging scientific approaches and applications for the conduct of quantitative modeling and simulations in generic drug development, especially for complex and locally acting products, and (2) gain inputs regarding opportunities and knowledge gaps related to the use of quantitative modeling and simulation to inform regulatory decision making through the product lifecycle. The FDA will use the information gained through the workshop to support product-specific guidance development, improve pre-ANDA interactions with applicants, increase the quality and efficiency of regulatory reviews, and identify a next generation modeling and simulation toolset for complex and locally acting products. More information

CDER SBIA extended webinar: Electronic Drug Registration & Listing Using CDER Direct (Oct 5)

This in-person and on-line event is intended to educate and assist all drug firms with the registration and listing process. Each session will focus on a specific submission (Establishment Registration, Product Listing, Listing Recertification, Labeler Code Requests, 503B Product Reporting) and walk through the creation and submission of each using FDA’s free authoring tool: CDER Direct. Additionally, for those who attend in person, experts and helpdesk technicians will be on hand to answer regulatory and technical questions, and assist with submissions. More information

Public Workshop - Voluntary Medical Device Manufacturing and Product Quality Program (Oct 10)

The FDA is announcing a public workshop entitled "Voluntary Medical Device Manufacturing and Product Quality Program." The purpose of the workshop is to announce the proposed framework and preliminary outline of a voluntary pilot program that recognizes an independent assessment of manufacturing and product quality. The workshop is intended to discuss the framework of the voluntary pilot program, information on the independent assessment, details of participation, rules of engagement, monitoring and performance expectations, as well as potential modifications to FDA's oversight actions in response to demonstrated manufacturing quality performance. More information

Patient Engagement Advisory Committee Meeting Announcement (Oct 11-12)

The FDA announces a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (PEAC). The general function of the committee is to provide advice and recommendations to the Agency on complex issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public. This meeting will be the inaugural meeting of a new advisory committee. DATES: The meeting will be held on October 11, 2017, from 1 p.m. to 5 p.m. and October 12, 2017, from 8 a.m. to 5 p.m. ADDRESSES: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy, Gaithersburg, MD 20877. The hotel's telephone number is 301-977-8900. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. More information

Cellular, Tissue and Gene Therapies Advisory Committee Meeting Announcement (Oct 12)

The Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) will meet in an open session to discuss and make recommendations on the safety and effectiveness of Biologics License Application (BLA) 125610, voretigene neparvovec, submitted by Spark Therapeutics, Inc. The proposed indication (use) for this product is treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. More information

Health Canada and FDA Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (Oct 19)

The FDA is announcing a regional public meeting entitled ‘‘Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Human Use (ICH)’’ to provide information and receive comments on the current activities of ICH as well as the upcoming meetings in Geneva, Switzerland, in November 2017. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting. The purpose of the public meeting is to solicit public input prior to the next ICH Assembly meeting and the expert working groups meetings in Geneva, Switzerland, scheduled for November 11 through 16, 2016, at which the discussion of the topics underway will continue. More information

Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access (Oct 20)

The FDA is hosting a public workshop titled Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access; Public Workshop. The workshop is free to attend and open to the public. Additional details will be posted as they are available. Please check the Federal Register and this website in the coming weeks. More information

Public Workshop - Cardiac Troponin Assays (Nov 28)

The FDA is announcing the following public Workshop entitled "Cardiac Troponin Assays." The purpose of the workshop is to discuss the development of innovative troponin assays designed to aid in the diagnosis of Myocardial Infarction (MI) and additional clinical uses of these assays. The workshop is intended to enhance engagement with stakeholders to facilitate device development and to discuss scientific and regulatory challenges associated with the analytical and clinical validation methods for troponin assay devices. More information

RESOURCES

For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program

Comunicaciones de la FDA sobre la seguridad de los medicamentos en español

Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible para proporcionar versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information en druginfo@fda.hhs.gov. Comunicaciones de la FDA

MedWatchLearn - Practice Reporting to FDA!

This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA. More information

FDA Expert Commentary and Interview Series on Medscape

As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices More information

Cardiovascular and Endocrine Liaison Program

The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with FDA. More information

Medical Product Safety Network (Medsun)

Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety. More information

FDA Basics

Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information

FDA Voice

FDA voice is the official blog from FDA's senior leadership and staff. More information

CIENCIASMEDICASNEWS

miércoles, 6 de septiembre de 2017